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FDA (Device enforcement)Recalled 2020-01-21closedclass ii

Medline Industries Inc: Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

Is my product affected?

Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

  • UPC 10888277056350

Check against the official notice below — it lists the full affected range.

What happened

Medline Industries Inc. has recalled 122 units of the Medline ROBOTIC-LF Complete Delivery System (model CDS984543B, lot 20AKA927, expiration date September 30, 2020) distributed exclusively to three California medical facilities. The sterile pack inside these devices did not complete a full sterilization cycle, which means the sterility of the internal components cannot be guaranteed.

The recall affects only the three named California hospitals and medical facilities: Torrance Memorial Medical Center in Torrance, Hoag Memorial Hospital in Newport Beach, and Owens/Minor VMI TEM in Ontario. The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

Details from the source

Reason for recall: The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed. Distribution: California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103 Quantity: 122 Lot/code info: REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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